Trastuzumab (Herceptin®) is a humanized monoclonal antibody used in the treatment of HER2-positive cancers. Trastuzumab binds to domain IV of the extracellular domain of the HER2/neu receptor. Cells treated with Trastuzumab undergo cell cycle arrest during the G1 phase. It has been suggested that trastuzumab does not alter HER-2 expression, but decreases activation of AKT.
Sample Type:Serum and plasma
Intended Use:This kit is designed to measure trastuzumab with high specificity and enhanced sensitivity. The assay design utilizes a pair of antibodies that allows the detection of the whole trastuzumab molecule in biological matrices.
Sensitivity:1.25ng/ml
Recovery:1000ng/mL of Trastuzumab was spiked in 10 lots of human serum. Recovery ranges are from 91-117% with an average recovery of 106%.
Specificity:hIgG1, Rituximab, and Infliximab prepared at 250ng/mL were assayed and exhibited no cross-reactivity or interference.
Test Principle:This assay employs the sandwich enzyme immunoassay technique. Anti- Trastuzumab is coated onto a 96 well microplate. Calibrator, quality control samples (if desired) and test samples are pipetted into the appropriate wells. Trastuzumab present in biological matrices is bound by the immobilized anti- Trastuzumab antibody. After washing away any unbound substances, enzyme linked anti- Trastuzumab antibody is added to the wells. The plate is washed to remove any unbound antibody-enzyme reagent and a substrate solution is added to the wells for color development. The color development is proportional to the amount of Trastuzumab present in test samples. The color development is stoppedand the intensity of the color is measured.
Storage and Stability:Store kit components at -20°C unless specified otherwise. Unopened kit is stable for 6 months after receipt. For maximum recovery of product, centrifuge small tubes on pulse setting prior to opening.
